Ethics and Research with Children

A Case-Based Approach

Edited by Eric Kodish, M.D.

In this edited volume, a diverse group of scholars present and discuss challenging cases in the field of pediatric research ethics. After years of debate and controversy, fundamental questions about the morality of pediatric research persist: Is it ever permissible to use a child as a means to an end? How much authority should parents have over decisions about research that involves young children? What should be the role of the older child in decisions about research participation? How do the dynamics of hope and desperation influence decisions about research involving dying children? Should children or their parents be paid for participation in research? What about economic incentives for doctors, researchers and the pharmaceutical industry? Most importantly, how can the twin goals of access to the benefits of clinical research and protection from research risk be reconciled?

Ethics and Research with Children

A Case-Based Approach

Edited by Eric Kodish, M.D.

Description

In this edited volume, a diverse group of scholars present and discuss challenging cases in the field of pediatric research ethics. After years of debate and controversy, fundamental questions about the morality of pediatric research persist: Is it ever permissible to use a child as a means to an end? How much authority should parents have over decisions about research that involves young children? What should be the role of the older child in decisions about research participation? How do the dynamics of hope and desperation influence decisions about research involving dying children? Should children or their parents be paid for participation in research? What about economic incentives for doctors, researchers and the pharmaceutical industry? Most importantly, how can the twin goals of access to the benefits of clinical research and protection from research risk be reconciled? Following an introductory overview by editor Eric David Kodish, the book is divided into three sections of case studies: Research Involving Healthy Children, Research Involving At Risk Children, and Research Involving Children with Serious Illness. Each case raises compelling ethical issues, and the analysis presented in each chapter illuminate the challenges posed across a wide spectrum of both research protocols and stories of individual case-based approach, this book provides a balanced and through account of the enduring dilemmas that arise when children become research subjects.

Ethics and Research with Children

A Case-Based Approach

Edited by Eric Kodish, M.D.

Table of Contents

1. Ethics and Research with Children, Eric KodishPart I: Research Involving Healthy Children 2. Evaluating benefits and harms in research on healthy children, Paul Miller and Charles Weijer3. Optimizing risk and benefit: The case of Rotavirus Vaccine, Susan Coffin and Robert M. Nelson4. Prospects and perils in the regulation of community based research involving children, John Lantos and Molly Martin5. Adolescent research and parental permission, Alan Fleischman and Lauren Collogan6. Recruitment of pregnant, minor adolescents and minor adolescents at risk of pregnancy into longitudinal, observational research: The National Children's Study, John Santelli, Gail Geller, Donna T. Chen, Marjorie A Speers, Jeffrey R. Botkin, and StacyLaswellPart II: Research Involving At-Risk Children 7. The ethics of newborn screening Diabetes research, Lainie Friedman Ross8. Payments for participation of children in research, Douglas S. Diekema9. Justice, lead and environmental research involving childre, Robert M. Nelson10. Behavioral Research with Children: The Fenfluramine challenge, Gerald P. Koocher11. The ethics of predictive genetic testing in prevention trials involving adolescents, Gail GellerPart III: Research Involving Children With Serious Illness 12. Research ethics and maternal fetal surgery, Rebecca Dresser13. Testing drugs in developing countries: Pediatric research ethics in an international context, Michelle Eder14. Research and innovation in pediatric surgery: The problem of Hypoplastic Left-heart Syndrome, Joel Frader and Erin Flanagan-Klygis15. Near the boundary of research: Roles, responsibilites and resource allocation, Christopher Church, Victor M. Santana, Pamela S. Hinds, and Edwin M. Horowitz16. Children and Placebos, Jessica Berg17. When eligability and criteria clash with personal treatment choice: A dilemma of clinical research, Benjamin Wilfond and Fabio Candotti18. Involving children in decisions about research and treatment for life shortening illness: A proposal for shuttle diplomacy and negotiation, Myra Bluebond-Langner, Amy DeCicco, and Jean BelascoIndex

Ethics and Research with Children

A Case-Based Approach

Edited by Eric Kodish, M.D.

Author Information

Dr. Eric Kodish is a teacher, researcher, and physician who cares for children with cancer and blood diseases. He is the Chairman of the Department of Bioethics at The Cleveland Clinic Foundation and a Professor of Bioethics, Pediatrics and Oncology at the Cleveland Clinic Lerner College of Medicine at Case Western Reserve University. His primary rersearch interest has been the study of informed consent for pediatric leukemia trials. He is an appointed member of the Committee on Bioethics of the American Academy of Pediatrics, and chairs the Bioethics Committee of the Children's Oncology Group. He has been active in multiple roles at the National Institutes of Health and the Food and Drug Administration, and is a member of the Secretary's Advisory Committee on Human Research Protections Subcommittee for Research Involving Children.

Ethics and Research with Children

A Case-Based Approach

Edited by Eric Kodish, M.D.

Reviews and Awards

"The 18 cases selected demonstrate a remarkable range of clinical scenarios and ethical difficulties involving participants from the maternal/fetal dyad to neonate, young child, and adolescent." --IRB: Ethical and Human Research

"The book achieves its ambitious stated purpose: a test for students of medical and research ethics; a handbook for members of institutional review boards, pediatric investigators, and government officials; a resource for clinicians whose patients and their parents may ask about clinical trials; and a guide for parents and children thinking about taking part in clinical research." --The Lancet

"This is an excellent resource for individuals conducting and reviewing research involving children. As there are so few publications addressing the ethics of research with children, this book will be a welcome addition to researchers, students of bioethics, ethics committees, and IRB members and staff." --Doody's

"The practical aspects of this book are its strength; its case-based approach will be most useful for researchers struggling with the ethical dilemmas raised by their investigations...This book will help researchers whose work involves children to navigate the ethical challenges of their investigations, and it will remind bioethicists of the practical concerns of researchers."--The New England Journal of Medicine

"Ethics and Research with Children: A Case-Based Approach is a primary text for anyone conducting pediatric clinical research. The case-absed approach illuminates the practical details behind each chapter's recommendations and conclusions."--Journal of Clinical Research Best Practices